Animal health diagnosis

ABSTRACT

Laboratory test data are analyzed in relation to the health assessment data of an animal together with the genetic data related to that same animal. These data are relevant to the likely morbidity, likely longevity, and/or the potential risk for disease or disorder for the animal, including temperament, immune stimulation and cellular inflammatory response mediators, markers for neoplastic or paraneoplastic change, inherited organ dysfunction or dysplasia, autoimmune thyroiditis, mammary cancer, immune surveillance markers, and inherited bleeding tendency. A panel of tests relates to at least one of endocrine function, immunologic function, gastrointestinal function and nutritional analysis, inborn errors of metabolism, paternity, DNA fingerprinting, hemostasis and coagulation function, vaccinal antibody status, adverse and potential adverse vaccine reaction, infectious diseases, pathology, blood typing and bone marrow analysis, cell cytotoxicity, cytokine and allergy testing, and markers of neoplastic and paraneoplastic change.

RELATED APPLICATION

[0001] This application relates to application Ser. No 09/419,192(Dodds) entitled Animal Genetic And Health Profile Database Management,and filed Oct. 15, 1999, the contents thereof are incorporated byreference herein.

TECHNICAL FIELD

[0002] This invention is concerned with animal health diagnosis. Moreparticularly the invention is directed to the testing, diagnosis andprediction of diseases and disorders of animal companions, for instancedogs and cats.

[0003] Further this invention relates to a method, system and apparatusfor the management of comprehensive and cumulative genetic and healthassessment databases in relation to animals worldwide. In particular,the invention relates to a bioinformatics system and its implementationin relation to animal biological data.

BACKGROUND OF THE INVENTION

[0004] Breeders, owners, and caregivers of animals which can becompanions, such as dogs, cats, horses, farm, food, or zoo animals, andwildlife, have a need to understand their physical and biologicalattributes, genetic makeup, heritable disease, and disorder background,and longevity.

[0005] Substantial investments in time, effort and financial resourcesare made by the breeders, owners, and caregivers of these animals,particularly purebred animals, to characterize their health state andpredict their morbidity, mortality and longevity. Resources areseparately directed to obtaining information about their geneticbackground. There is also a need to conduct periodic comprehensivehealth assessments of animals.

[0006] The probability that an individual animal will develop a specifichealth-related condition in its lifetime is a product of complexinteractions between its genetic makeup, environmental influencesincluding diet, and agents of disease (e.g., chemical, physical, orbiological) that it encounters. Perhaps the best indicator of overallhealth of an individual animal or breed is longevity.

[0007] The physical attributes, and other descriptive and healthassessment information is generally termed in this application as thephenotypic information. Genetic disorder information is termed in thisapplication as the genotypic information. Generally, these are twodistinct and differing sets of information.

[0008] Phenotype Data

[0009] The physical descriptive and health assessment profiles includecharacteristics such as the physiological, pathological,endocrinological, hematological, epidemiological, behavioral, andimmunological data from parameters such as phenotype, breed, lifespan,health history, and presence of infectious diseases and metabolicdisorders. All of this is part of the phenotypic information. A healthassessment profile of an animal typically relates to a particularsubject of the group, as opposed to the group of animals as a whole.Generally, the phenotype is the genetic nature of an organism that isrevealed by visible characteristics or measurable performance, incontradistinction to the genotype, which may not be evident without abreeding test or genetic map.

[0010] Laboratories having a central database processing resource (CDPR)as well as in-office laboratory equipment at veterinary hospitals orclinics are used for analyzing blood and other biological samples of asubject animal. This is a system for obtaining the phenotypicinformation. Communication systems are known for connecting theselaboratories with veterinary clinics through a telephone and/or faxconnection on an automated basis. These systems permit the veterinarian,animal hospital, or other authorized person (collectively orindividually termed the “remote user”) to receive the health assessmentprofile and basic descriptive identifying data, namely phenotypicinformation, of a subject animal from the CDPR. Until recently, it wasnot possible for the remote user to access the CDPR directly to obtainthis phenotypic information of a subject animal.

[0011] It is known for the breeder and/or owner of animals, such aspurebred companions in the nature of dogs, cats, and horses, or animalsof mixed breeding, to obtain health assessments of their animals. Theowners obtain these data by submitting blood or other body fluid andtissue samples of their animals, usually through a veterinarian orveterinary clinic, to a laboratory for analysis of the biological,physiological, or pathological condition, namely the physical health ofthe animal. These data are then reported to the owner through theveterinarian or veterinary clinic. The data also can be stored on theCDPR of the laboratory. Additionally, for each subject animal, thephenotypic data can be stored on a computer storage system at theveterinary clinic or in a computer storage system of the owner and/orbreeder. The retrieval of the data can be electronically, by voice, hardcopy, or fax as required.

[0012] Seeking, obtaining and storing this phenotypic information isdriven by the needs of the animal breeder, owner or the agent of theowner and the animal's healthcare provider. This information is of anature that it is the primary information sought to resolve theclinical, diagnostic, management, and therapeutic needs of an animalsubject when the animal is in need of periodic wellness examination, isill, or is to be restored to a well condition. These data are theessential information resorted to by the clinician in the care ofanimals.

[0013] Genotype Data

[0014] The genotypic information relates to genetic mapping, geneticbackground, and genetic screening databases. This includes data obtainedfrom the pedigree, family history, heritable physical characteristics,genetic screening tests, DNA testing, genomic mapping, and relatedlaboratory assessment of the gene product for known or suspectedcongenital and heritable traits. In this application, the term “geneproduct” means the specific phenotypic characteristic(s) resulting fromthe expression of the genotype, and may include certain specificlaboratory test data.

[0015] This second aspect of data associated with the animals is thegenetic or genotype data or information. These data are typically usedto estimate the presence and prevalence of disease or disorder amongdifferent breeds or kinds of animals. These data are currently availableon some select clinical research databases, in book form, hard copy, orin genetic disease registries.

[0016] When retained in a genetic disease registry, the data typicallylist only those animals that are not affected with or carrying theheritable trait in question. The abnormal or non-normal conditions(affected with or carriers of the heritable trait) are normally thesubject of confidential knowledge of a breeder and/or owner, and not thesubject of a generally accessible database. This is retained asconfidential by the owners either for financial reasons, risk reasons,legal liability reasons, or personal reasons.

[0017] The genotypic information typically relates to individualanimals, or a group or class of animals and is most often storedmanually in a non-CDPR facility. It is not typically stored byveterinarians in a clinical setting, since the genotypic data is aspecialist form of data used mainly for cataloging and research ofdiseases and disorders among animals. It is also not generally availablefor access to assist in the clinical analysis, diagnosis, andtherapeutic management of animals.

[0018] This genotypic information, namely the physical characteristicsand genetic makeup (pedigree), heritable disorder history, and relatedhealth history of animals in the group is usually manually recorded bybreeders, owners, and researchers of companion and other valued animals.The genetic constitution of an organism includes genes without visibleeffects as well as those revealed by the phenotype. It may refer to allthe genes or to a single pair of alleles. The genotypic information istransmitted manually to and from persons or local and national genotypicdatabases maintained for specific disorders, and designed to fosterresearch into diseases and disorders, rather than being readilyaccessible to users for clinical purposes in the manner of phenotypicdata on a CDPR.

[0019] Some of the genetic data are available on registries related tospecific diseases or disorders, for instance, hip dysplasia, eyeconditions, thyroid conditions, and blood conditions. Suchdisease-specific registries are usually set up either by identifyingaffected animal breeds, or are indexed by disease or disorder. Thegenetic information databases are generally closed (kept confidential),but in some cases may be open to researchers or members of groups,associations, and clubs.

[0020] Failings of the Existing Systems

[0021] To promote better health among animals, which can be animalcompanions, sport animals, farm animals, and the like, such as canine,feline, equine, bovine, porcine, caprine, ovine, and zoo animals orwildlife, it is important to secure accessible genotypic or geneticinformation databases. It is also important to be able to relate thesegenotypic databases to the health assessment profiles or phenotypicdatabases of particular subject animals.

[0022] Many purebred animals are valuable, and so it is important toobtain their descriptive phenotypic information, and periodic healthassessment data throughout their lives, and also to incorporate theirgenotypic information in order to promote and maintain effective highquality and healthy breeding stock, and maximize their lifespan. Thephenotype data for an animal include the health assessment profile,breed, and the physical characteristics of the animal. The genotype datainclude the genetic map, pedigree, family history, genetic screeningtests, and disorder and disease characteristics of a particular animal,animal family, line, or group of animals.

[0023] There is a need to develop these data in a cumulative,comprehensive, and dynamic system of database management to therebyenhance the health predictability, and longevity of animals.

[0024] This type of comprehensive and cumulative database on individualor groups of animals needs to be preserved and shared locally,regionally, nationally, and globally. A mechanism to do this ispresently not known due to the various constraints surrounding each ofthe two types of databases. The phenotype database storage, use, andaccess is fashioned, formed and structured for use by clinicallaboratories and veterinarians. The genotype information is fashionedand structured generally for clinical research and breeder/owner uses asopposed to clinical medical uses.

[0025] It is not known to store and/or present phenotypic informationand genotypic information as a comprehensive and cumulative assessmentof individual animal subjects, families of subjects, breeds of subjects,or species of animals in a computerized format which is availablethrough computer networking to authorized remote users.

[0026] Accordingly, there is a need to relate different databases fromanimals, animal groups or species, in a manner to permit enhancement ofthe animal kingdom for breeding and growth in a healthy manner with aminimum of disease (reduced morbidity and mortality) and increasedlongevity.

[0027] As the above demonstrates, there is a need for a new databasemanagement bioinformatics scheme and relational database, together withcomputerized networks that manage, analyze, and/or integratecomprehensive and cumulative animal health assessment data and geneticidentifier, genomic mapping, and genetic assessment data. Acomprehensive approach to animal health and genetic selection ormanagement of animals, and their clinical care is the subject of thepresent invention.

[0028] Current laboratory and research systems and computerization havenot achieved this, and nor have communication protocols been usedeffectively in this technological area to facilitate such a relationshipor relational bioinformatics database system for management anddissemination of this comprehensive and cumulative information.

[0029] More specifically, it is necessary in animal health diagnosis andcare that appropriate predictive testing for diseases and disorders ofanimals be achieved in order to reduce morbidity and mortality, andimprove the quality of life and lifespan. Currently this is not done inrelation to the health assessmant data of an animal together with thegenetic data related to that same animal. Current tests do not provideas much data as possible to attain correct diagnosis and disorderpredictions with the net result of an improvement in the quality of lifeand increased longevity. Moreso, currently available testing isunnecessarily complex and expensive in relation to the ability to be anaccurate predictor of diseases and disorders in animals, and hence theirlikely longevity.

SUMMARY OF THE INVENTION

[0030] The invention is directed to a method, apparatus and system ofobtaining, analyzing and reporting laboratory test data in relation tothe health assessmant data of an animal together with the genetic datarelated to that same animal.

[0031] These data include a panel of tests related to at least one ofendocrine function, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokine and allergy testing, and markers of neoplasticand paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal.

[0032] According to one aspect of the invention, health profiling of ananimal is effected to determine characteristics related to thetemperament of the animal which impacts on its longevity. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. Such test data relate to the level of neurotransmitteractivity of the animal. The data relate to at least one of the value ofserotonin, the gamma-aminobutyric acid (GABA), the dopamine, thenorepinephrine, the histamine, or the other neuropeptides of the animal.The value should fall within predetermined levels as a predictivedeterminant of the animal's temperament (passivity, assertiveness, oraggressivity).

[0033] One other aspect of the invention relates health profiling of ananimal to determine characteristics related to at least one of theimmune stimulation reaction, evidence of neoplastic or paraneoplasticchange, or the cellular inflammatory response of the animal. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

[0034] According to another aspect of the invention, health profiling ofan animal determines characteristics related to inherited organdysfunction or dysplasia of the animal, at least one of which isneuronal, neuromuscular or renal. Biological laboratory test data from abodily fluid or tissue of an animal are analyzed. The test data relateto an amino acid, carbohydrate, lipid or other metabolic component, bodyfluid or tissue marker of the animal. The data includes obtaining datarelated to at least one of the value of the methyl malonic acid, thefucose-containing cell metabolites, uric acid, normoglycemic glycosuria,amino acid uria, mannosidase containing cell metabolites, amyloiddeposition in tissues, neuronal ceroid lipofuscin deposition, anddeposition of gangliosides and other lysomal storage substrates of theanimal. The value should fall within predetermined levels as adeterminant of the inherited organ dysfunction or dysplasia.

[0035] According to a further aspect of the invention, health profilingof an animal determines characteristics related to autoimmunethyroiditis of the animal. Biological laboratory test data from a bodilyfluid or tissue of an animal are analyzed. The test data relate to aphysiologic or genetic marker for autoimmune thyroiditis of the animal.The data relates to at least one of the results of a comprehensivethyroid autoantibody test profile, DNA fingerprint (the gene map), andmarkers for immunoglobulin receptors on B-cells, T-cell receptors, andprotein products of the major histocompatibility complex (MHC) genes(Class I and II allellic HLA, DLA or equivalent antigenic specificities)of the animal. Example assays to screen for MHC genes includerestriction fragment length polymorphism (RFLP), polymerase chainreaction (PCR) RFLP, PCR sequence-specific oligonucleotides (SSO) andPCR sequence-specific primers (SSP). The values should fall withinpredetermined levels as a determinant of autoimmune thyroiditis.

[0036] According to a further aspect of the invention, health profilingof an animal determines characteristics related to presence of orsusceptibilty to mammary cancer of the animal. Biological laboratorytest data from a bodily fluid or tissue of an animal are analyzed. Thetest data relate to estrogen (estradiol-1713), estrogen receptors,interleukin (IL) 6, progesterone, and progesterone receptors. The valueshould fall within predetermined levels as a determinant of presence orsusceptibilty to mammary cancer.

[0037] According to a further aspect of the invention, health profilingof an animal determines characteristics related to the tissueenvironment of the eye and brain (ocular and blood-brain barrier) whichare sites protected from the normal immunologic surveillance mechanisms.Biological laboratory test data from a bodily fluid or tissue of ananimal are analyzed. The test data relate to the soluble and cellularimmune inflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphycyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

[0038] According to a further aspect of the invention, health profilingof an animal determines characteristics related to the tendency to bleedexcessively are determined. Biological laboratory test data from abodily fluid or tissue of an animal are analyzed. The test data relateto a comprehensive assessment of the hemostatic and coagulationfunction. The value should fall within predetermined levels as adeterminant of the presence of bleeding disorder.

[0039] The invention includes obtaining genetic data related to theanimal, and relating the genetic data related to that animal with thebiological data. Also the profiling includes obtaining data related tothe current health condition of the animal.

[0040] More particularly the invention comprises combining genetic dataof animals with health assessment data of animals thereby to permit ananalysis predicting health, disease and disorder probabilities andlongevity of selected animals. the combination is analyzed, and a reportis provided to a remote user based on the analysis the health assessmentdata of the animal and the genetic data.

[0041] In light of the above, there is provided by this invention asystem for managing animal diagnosis, including the performance ofspecific tests. The phenotypic and genotypic data and informationrelating to animals, particularly purebred animals can be used toenhance the prediction of disease and /or disorder.

[0042] The invention also provides a bioinformatics system forinputting, controlling, analyzing and outputting of a broad range ofcriteria related to the health, genetic background and longevity ofanimals. This includes a system concerning phenotype data and geneticdata relating to animals. Further, there is provided a system forscreening of genetic data and genomic mapping, and integrating thephenotype health assessment data and genetic identifier and assessmentdata in a CDPR. Moreover, there is provided a system for analyzing thehealth assessment or phenotypic data with the interrelated genetic orgenotypic data. Thereafter, those data and analyses are communicatedfrom the CDPR in a broad range and in a manner that has not previouslybeen possible.

[0043] The present invention offers a unique solution to above-describedproblems by providing an apparatus, method and system, in relation toanimals, for performing data analyses of biological specimens fromspecific subject animals or animal groups in relation to specificsubject animal or animal groups of genetic data. The apparatus, methodand system comprises a controller for obtaining, inputting, andanalyzing biological, physiological, and pathological test data togetherwith genomic mapping and genetic screening data into the CDPR.

[0044] The biological, physiological, and pathological data of thesubject animal or animal group and the genetic data of the subjectanimal or animal group are communicated to a remote user as raw data oras related, analyzed biological, physiological, and pathological dataand genetic data. The remote user can also appropriately access the CDPRto input data to, or obtain data from, the CDPR.

[0045] The CDPR includes at least two databases, one of the databasescontains genetic information in relation to animals and the other is aphenotypic database.

[0046] The genetic database is either a specific file of a selectedanimal or a generalized animal database relating to groupcharacteristics, and is cross-relatable with the phenotypic database ofparticular selected subject animals.

[0047] Additionally other databases can be used and cross-related tothese databases. The genetic database includes data from selectedanimals, animal families, animal breeds and/or data related to selectedanimal diseases and/or disorders. Other databases include those relatedto genetic markers or maps of animals, databases related toepidemiology, purebred animal ownership, identification registries, andstudbook registries.

[0048] The phenotype, health profile, or health assessment databasecontains data which is mostly phenotypic. The genotype database includesdata which is in the category of mostly genotype or genetic and whichmay include a second category of some phenotype data which predicts ormanifests the genotype and genetic data. The invention includes relatingthe phenotypic data to either one or both types of the genotypic data.

[0049] Information in the databases are used to build computer drivenstatistical models to predict the occurrence of specific diseases andlongevity for individual animals on a breed-by-breed or family and groupbasis. Multivariate statistical techniques are used including multipleregression, logistic regression, and Cox proportional hazards. As newdiagnostic technology and genomic information become available, thedatabase is continually expanded and the statistical models are updatedto enhance predictive ability. This ability to predict the occurrence ofdisease or disorder is used to develop and evaluate screening programsin veterinary medicine in order to detect disease earlier, therebyimproving the outcome and quality of life for animals and their owners.The information is also used to design disease prevention programs basedon dietary/environmental modification and selective breeding. Thedatabase is also used to explore previously unsuspected relationshipsbetween specific diseases such as cancer and diet, vaccination, orchemical exposures.

[0050] There is provided means for inputting data into the geneticdatabase and phenotypic database, and other databases, storing the datain these databases, analyzing the data in a relational sense from thedifferent databases, and retrieving the data from these databases,namely the databases which are part of the CDPR.

[0051] A further aspect of the invention is the accessibility of thehealth assessment database and/or genetic database or other databases ofthe CDPR by the remote user selected on the basis of password, securitycontrol, and financial payment such that the data can be transmittedinto and from the CDPR by a computer network. Use of selected passwords,encryption systems, and payment systems are employed to facilitate andrestrict the flow of data in and/or out of the databases. Alerts can beset up to advise of attempts at unauthorized access to the CDPR. Thecomputer network may conveniently include the Internet.

[0052] As required, the data in the CDPR can also be distributed tomultiple authorized remote parties, namely third parties for research orother analysis. The invention also includes a method and system forachieving this.

[0053] Further aspects of the present invention will become apparent inthe course of the following description and by reference to the attacheddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0054]FIG. 1 is an overall view of a web-based system to provide accessto a database management system of an animal genetic database and ahealth assessment database of the invention, in relation to theInternet.

[0055]FIG. 2 is a graphical illustration of a computer network, namelythe Internet.

[0056]FIG. 3 is a block diagram of an exemplary computer system forpracticing various aspects of the invention.

[0057]FIG. 4 is a view of a browser for the database management systemfor accessing an animal genetic database and a health assessmentdatabase of the invention.

[0058]FIG. 5 is a basic flow diagram illustrating an exemplary processby which an operator of a CDPR receives and transmits data relating tohealth assessment and genetic information.

[0059]FIG. 6 is a detailed flow diagram of the system steps employed inone embodiment of the present invention wherein a remote user accessesand outputs data.

[0060]FIG. 7 is a detailed flow diagram of the methods and stepsemployed by a remote user to add data to the database.

[0061]FIG. 8 is a flow chart illustrating an exemplary process by whichthe laboratory dynamically contributes, transmits and receives dataassociated with health assessment and genetic data to the CDPR.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0062] The present invention will now be described in detail withreference to a few preferred embodiments thereof, as illustrated in theaccompanying drawings. In the following description, numerous specificdetails are set forth in order to provide a thorough understanding ofthe present invention. It will be apparent, however, to one skilled inthe art, that the present invention may be practiced without some or allof these specific details. In other instances, well known process stepshave not been described in detail in order to not unnecessarily obscurethe present invention. Genetic Screening and Counseling of PurebredAnimals The common practice to line-breed and inbreed purebred animalsfacilitates the transmission and recognition of congenital and heritabledefects. Large-scale screening programs for the identification ofgenetically affected and carrier animals are an effective way todiscover and eventually control the frequency of these defects withinthe population at large. Screening programs of this type have been usedsuccessfully in humans for many years (e.g. Tay-Sachs disease,phenylketonuria) and more recently have been applied to animals (e.g.mannosidosis in cattle; hip dysplasia, eye, blood and heart diseases indogs). Genetic screening may be essential to the survival of breeds inwhich mild or moderately severe defects have been propagated unknowinglyfor many generations.

[0063] It is important that the top-producing sires and foundation damsof a breed be screened for conditions prevalent in that breed or in thespecies generally, because they represent the major nucleus of geneticmaterial for the current and future decades. Most purebred animalsraised today have evolved over the years from a relatively small genepool. Even though a particular genetic disorder may initially have beenrecognized in a specific line or family within a breed, all importantbreeding stock of the breed need to be screened because their similargenotype. evolved from the original restricted gene pool. If thisapproach is not taken, the frequency of genetic defects in the breedwill inevitably increase and have a negative impact on overall healthand longevity.

[0064] Depending on the mode of inheritance, different approaches mayneed to be applied for the detection and control of genetic disorders.It is advantageous to be able to select against heterozygotes (carriers)rather than have to eliminate affected individuals from a breedingprogram once the condition is manifested. Control and elimination of thedisease by testing are feasible and reliable in cases where theasymptomatic or carrier state has an expressed phenotypic, biochemicalmarker (e.g., as measured in a blood, urine or saliva test,electrocardiogram, skin biopsy, eye examination, or hair analysis). Somecurrent examples include testing for bleeding disorders like vonWillebrand disease and hemophilia; autoimmune thyroid disease leading tohypothyroidism; the various eye, heart, metabolic enzyme and storagedisorders; and the bone and neuromuscular diseases. Coupled with thisapproach to eliminating undesirable traits is the necessity to evaluatebreeding stock regularly for overall soundness, reproductive health andperformance, and longevity.

[0065] Features Related to Genetic and Other Data Associated withAnimals

[0066] A. Physical Characteristics of Disease

[0067] In the early days when animal breeders began recognizingrecurring symptoms of disease states or physical characteristics, theundesirable features of these traits led them to select away from theproblems by test mating and eliminating affected animals from thebreeding pool. While this remains one way to select against inheritedand congenital diseases, more reliable approaches have been implementedby screening for biochemical markers and most recently by usingmolecular genetic techniques.

[0068] A comprehensive worldwide database contains the followinginformation for individual purebred animals:

[0069] Host characteristics: age, sex, neuter status, pedigree, height,weight, body mass index, coloration and markings, eye color, etc.

[0070] Diet: type and amount of dog and human foods consumed, vitaminand mineral supplements, frequency of feeding. This is used to derivethe percentage of calories derived from fat, carbohydrate, and protein.

[0071] Medical history: occurrence of diseases, infections, etc.,including date of onset, treatment, duration, and outcome, cause ofdeath and method of diagnosis; type and amount of medications used fortreatment or prevention of disease; type and frequency of vaccinations.

[0072] Personality and temperament: based on previously used personalityscales.

[0073] Laboratory data: consists of routinely collected blood, serumchemistry tests, urinalysis, etc., as well as laboratory tests performedto screen for or diagnose specific conditions such as immune-mediatedthyroiditis, hypothyroidism, cancer, etc.

[0074] Special diagnostic test results: include tests for hip dysplasia,congenital eye diseases, congenital heart diseases, blood disorders, andother suspected inherited disorders as tests become available.

[0075] Genetic information: derived from the canine genome project aswell as tests for specific inherited conditions such as progressiveretinal atrophy, hemophilia, and von Willebrand disease.

[0076] B. Phenotypic Markers of Disease

[0077] While animal breeders (e.g., of purebred dogs) for the most parthave endorsed the long standing genetic screening programs for hipdysplasia and blood and eye diseases, emphasis on other geneticdisorders has arisen, now that the major infectious, parasitic,nutritional and traumatic diseases have been addressed and controlled toa large extent by modem veterinary medical practice. Furthermore, mostanimal fanciers become involved in breeding and showing their animals asa hobby rather than a prosperous enterprise as might apply to livestockor the performance racing industry. The intense commitment to this hobbywith its attendant social praise for the successful breeder andexhibitor, poses ethical dilemmas when prize-winning animals areidentified as carriers of a particular genetic disorder.

[0078] For about three decades, veterinary and comparative geneticistshave developed and relied upon physical and biochemical markers ofspecific genetic traits to identify carrier and affected animals. Thesemethods aimed to produce reliable, practical, and affordable tests thatwould be predictive of the gene product, and therefore the genotype of aparticular genetic disorder. To be considered accurate and predictive,retrospective analyses of data developed from these testing programswere compared to the pedigrees of animals being screened as a means ofvalidating the tests. Such genetic screening tests would be consideredreliable if they correctly identified animals as having the normal andabnormal genotypes at least 80% of the time.

[0079] An important indicator of overall health of an individual animalor breed is longevity. Relationships between a specific health-relatedcondition and an animal's genetic, environmental influences and lifespanhave been characterized, in part, for several important diseases of dogsincluding bone cancer (osteosarcoma) and gastric dilatation-volvulus(GDV).

[0080] Osteosarcoma: The risk of osteosarcoma increases with increasingage, increasing weight and increasing height. Compared with the Germanshepherd breed, the highest risk of osteosarcoma occurs among large andgiant breeds, while small breeds have reduced risk. Furthermore, therisk of osteosarcoma is increased two-fold in neutered dogs.

[0081] GDV: Factors that increase the risk of GDV in purebred dogs aremale gender, being underweight, eating only one meal per day, eatingrapidly, and a fearful temperament. Factors that decrease the risk ofGDV include a happy temperament and inclusion of table foods in thediet. The lifetime risk of developing GDV in large and giant breed dogsis 20% and 23%, respectively, whereas the lifetime risk of dying of GDVfor these breeds is 6%.

[0082] Similarly, the comparative longevity of different dog breeds hasbeen described using the age of death and other descriptivecharacteristics of more than 38,000 dogs that were included in a largeveterinary database. Predictable relationships were found between thebreed and size of dogs and the average age of death. It was noted thatdogs are unique among animal species in having a more than 50-folddifference in adult body size and a corresponding large difference inlongevity between the smallest and biggest dog breeds. Since these dogbreeds have more than 99% of their genome in common, it suggests thatthe genetic code for both size and longevity is contained within a verysmall part of the dog's genome. As mapping of the canine genomeprogresses, it should be possible to identify not only genes that codefor specific diseases such as cancer and GDV, but also for the genesthat determine body size and longevity.

[0083] C. Genotypic Markers of Disease

[0084] Recent advances in molecular genetics have focused on mapping thehuman genome, and this has stimulated interest in developing parallelgenetic maps for animals. For example, it is estimated that a minimum often years and several million dollars will be needed to map the caninegenome. Once developed, a genetic map provides information about therelative order and placement of genes or specific DNA markers onspecific chromosomes. This allows one to locate specific regions onchromosomes where genes of interest are likely to be found. Once amolecular marker is identified close to a specific gene of interest,screening tests for this particular marker can be used to identifyindividuals carrying or expressing the trait.

[0085] Other information in relation to genetic screening and healthassessment is contained in the literature references listed at the endof the specification. The contents of these materials are incorporatedby reference herein.

[0086] Some of the characteristics of animals with which this inventionis concerned are the following: Genotype & Some Mostly Mostly Phenotype(Gene Animal Characteristics Phenotype Genotype Product) Species XPurebred X Crossbred X Mixed breed X Size X Weight X Age X Sex XLifespan X Body type X Color X Family history X DNA testing X Genomicmapping X Blood type X Thyroid function X von Willebrand factor XHemophilia X Other bleeding disorders X Glucose X Cholesterol X Alkalinephosphatase X Alanine aminotransferase X Bile acids X Cortisol XCataracts X Progressive retinal atrophy X Microophthalmia X Dry eye(KCS) X Hip dysplasia X Arthritis X Temperament X Ruptured cruciateligament X Hemolytic anemia X Urinalysis X Kidney stones X Bloat(gastric dilatation) X Pyoderma X Seborrhea X Sebaceous adenitis XUmbilical hernia X Inguinal hernia X Epilepsy X Heartworm disease XCardiomyopathy X Patent ductus arteriosus X Immunoglobulin levels X

[0087] In the category of genotype and some phenotype, the phenotypecomponent (measurable gene product) is typically less than 20%.

[0088] Diagnostic Testing

[0089] The development of one or more assays or techniques forperforming the invented testing protocols, standards and procedures ofthe present invention is straightforward, and within the knowledge of aperson skilled in the art. The contents of U.S. Pat. No. 5,830,7009(Benson) entitled “Detection Method for Homologous Portions of a Classof Substances” is indicative of some of the tests and formats that arepossible. The contents of that patent are incorporated by referenceherein.

[0090] One or more of a panel of tests relate to at least one ofendocrine function, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokines and allergy testing, and markers of neoplasticor paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal.

[0091] The following are some examples of diseases, disorders, andphysiologic states that use one or more of the diagnostic test panelsset out below:

EXAMPLES Example 1

[0092] Temperament and Longevity

[0093] Characteristics related to the temperament of the animal whichimpacts on its longevity are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. Such test datarelate to the level of neurotransmitter activity of the animal. The datarelate to at least one of the value of serotonin, the gamma-aminobutyricacid (GABA), the glutamate, the dopamine, the glycine, the aspartate,the acetylcholine, the norepinephrine, the histamine, the substance P,the vasopressin, the vasoactive intestinal peptide, the neurotensin, orthe other neuropeptides of the animal. The value should fall withinpredetermined levels as a predictive determinant of the animal'stemperament (passivity, assertiveness, or aggressivity).

[0094] Methods for measuring neurotransmitters are well known in theart. Neurotransmitters such as serotonin, epinephrine, norepinephrine,glutamate, and GABA can be measured by standard immunochemicaltechniques involving commercially available antibodies, eitherpolyclonal or monoclonal. Such antibodies are commercially availablefrom sources such as Sigma Chemical Company (St. Louis, Mo.). Theseimmunochemical techniques can involve either radioimmunoassay or otherwell-established assay techniques, such as ELISA (enzyme-linkedimmunosorbent assay). These neurotransmitters can also be measured bystandard non-immunochemical techniques such as gas chromatography.Neuropeptide neurotransmitters are preferably measured by immunochemicaltechniques.

[0095] Test panels Nos. 1, 2, 3, 8 and 10 set out below can be used toobtain data for this Example 1.

Example 2

[0096] Immune Stimulation and Cellular Inflammatory Response

[0097] Characteristics related to at least one of the immune stimulationreaction, evidence of neoplastic or paraneoplastic change, or thecellular inflammatory response of the animal are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

[0098] Methods for measuring lymphokines and other cytokines are wellknown in the art. These compounds are typically measured byimmunochemical techniques using commercially available monoclonalantibodies or other methods.

[0099] Test panels Nos. 1, 3, 4, 8, 9 and 10 set out below can be usedto obtain data for this Example 2.

Example 3

[0100] Inherited Organ Dysfunction or Dysplasia

[0101] Characteristics related to inherited organ dysfunction ordysplasia of the animal, at least one of which is neuronal,neuromuscular or renal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to an amino acid, carbohydrate, lipid or other metaboliccomponent, body fluid or tissue marker of the animal. The data includesobtaining data related to at least one of the value of the methylmalonic acid, the fucose-containing cell metabolites, blood or urineurate or uric acid metabolites, normoglycemic glycosuria, mannosidasecontaining cell metabolites, amino acid uria, amyloid deposition intissues, neuronal ceroid lipofuscin deposition, and deposition ofgangliosides and other lysomal storage substrates of the animal. Thevalue should fall within predetermined levels as a determinant of theinherited organ dysfunction or dysplasia.

[0102] Test panels Nos. 1, 3, 5, 9 and 10 set out below can be used toobtain data for this Example 3.

Example 4

[0103] Autoimmune Thyroiditis

[0104] Characteristics related to autoimmune thyroiditis of the animalare determined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to a geneticmarker for automimmune thyroiditis of the animal. The data relates to atleast one of the results of a comprehensive thyroid antibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities of the animal. Testassays to screen for MHC genes include restriction fragment lengthpolymorphism (RFLP), polymerase chain reaction (PCR) RFLP, PCRsequence-specific oligonucleotides (SSO) and PCR sequence-specificprimers (SSP). The value(s) should fall within predetermined levels as adeterminant of autoimmune thyroiditis.

[0105] Test panels Nos. 1, 2, 3 and 10 set out below can be used toobtain data for this Example 4.

Example 5

[0106] Mammary Cancer

[0107] Characteristics related to presence of or susceptibilty tomammary cancer of the animal are determined. Biological laboratory testdata from a bodily fluid or tissue of an animal are analyzed. The testdata relate to estrogen (estradiol-1713), estrogen receptors,interleukin (IL) 6, progesterone, and progesterone receptors. The valueshould fall within predetermined levels as a determinant of the presenceof or susceptibilty to mammary cancer.

[0108] Test panels Nos. 1, 2, 3 and 10 set out below can be used toobtain data for this Example 5.

Example 6

[0109] Immune Surveillance

[0110] Characteristics related to the tissue environment of the eye andbrain (ocular and blood-brain barrier) which are sites protected fromthe normal immunologic surveillance mechanisms are determined.Biological laboratory test data from a bodily fluid or tissue of ananimal are analyzed. The test data relate to the soluble and cellularimmune inflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphycyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

[0111] Test panels Nos. 1, 3, 5, 6, 8, 9 and 10 set out below can beused to obtain data for this Example 6.

Example 7

[0112] Inherited Bleeding Disorders

[0113] Characteristics related to the tendency to bleed excessively aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to acomprehensive assessment of the hemostatic and coagulation function. Thevalue should fall within predetermined levels as a determinant of thepresence of bleeding disorder.

[0114] Test panels Nos. 1, 7, and 9 set out below can be used to obtaindata for this Example 7.

[0115] Test Panels

[0116] The following are some specific diagnostic test panels andspecialized diagnostic tests and test groups used to monitor health,morbidity, mortality and longevity of animals and animal families, andto predict the potential risks of disease or disorder:

[0117] Test 1: Comprehensive Diagnostic Test Panel

[0118] Patient phenotypic descriptors and genotypicdescriptors/background; complete blood count (CBC) and platelet count,platelet size, platelet morphology; serum chemistry profile [e.g., AST(SGOT), ALT (SGOT), bilirubin (total, direct and indirect), alkalinephosphatase, GGT (GGTP), total protein, albumin, globulin, A/G ratio,cholesterol, BUN, creatinine, BUN/creatinine ratio, phosphorus, calcium,corrected calcium, calcium/phosphorus ratio, glucose, amylase, lipase,sodium, potassium, Na/K ratio, chloride, CPK, triglyceride, osmolality];complete thyroid profile (total T4, total T3, free T4 (ED or other),free T3, T3 autoantibody, T4 autoantibody, TSH, thyroglobulinautoantibody); and urinalysis, urine culture, and sensitivity, ifindicated.

[0119] Test 2: Diagnostic Test Panels for Endocrine Function

[0120] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all of selected tests from thefollowing list:

[0121] 1) Thyroid Function: total T4, total T3, free T4 (ED or other),free T3, T3 autoantibody, T4 autoantibody. Molecular screening forautoimmune thyroiditis including immunoglobulin receptors on B-cells,T-cell receptors, and major histocompatibilty complex (MHC) genes ClassI and II allellic HLA, DLA, or equivalent animal antigenic specificities(RFLP, PCR/SSO, PCR/SSP).

[0122] 2) Adrenal Function: cortisol (basal and after stimulation withACTH, or serially after suppression with high or low-dosedexamethazone); endogenous cortisol; and endogenous ACTH.

[0123] 3) Reproductive Function: testosterone; estradiol-173 ; relaxin(pregnancy diagnosis); progesterone; luteinizing hormone; estronesulfate; follicle stimulating hormone; vaginal cytology and/or culture;testicular cytology or biopsy; prostatic cytology, biopsy or wash;screens for ovarian or testicular remnants.

[0124] 4) Pancreatic Function: amylase; lipase; glucose; glucagon,trypsin-like immunoreactivity (TLI); insulin, fructosamine; glycosylatedhemoglobin.

[0125] 5) Parathyroid Hormone Function: parathormone; ionized calcium.

[0126] 6) Other Endocrine Function: aldosterone; 21 adrenal hydroxylase;vanylla mandelic acid (VMA, for epinephrine and norepinephrinemetabolities).

[0127] Test 3: Diagnostic Test Panels for Immunologic Function

[0128] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all of selected tests from thefollowing list:

[0129] Antinuclear antibody (ANA)—if positive, run double stranded,single stranded, speckled, anti-RNA levels; Coombs' testing (direct andindirect; elution or microbeads gel-test); rheumatoid factor; serumelectrophoresis—if abnormal, run immunoelectrophoresis, isoelectricfocusing, immunoblotting (Western, Northern, Southern blots);immunoglobulin levels (IgG, IgA, IgM, IgD and IgE); complement levels(C1, C1a, C1 esterase inhibitor, C3, C4, C5-C9); LE-prep testing; lupusanticoagulant (dilute Russell's viper venom test or dilutional inhibitortest); urine protein SDS-gel electrophoresis; fibronectin andanti-fibronectin antibody; flow cytometry with fluorescence activatedcell sorter (FACS, for leukocyte subsets and markers such as CD4⁺ andCD8⁺; leukocyte chemotaxis (leukocyte migration inhibition test,leukotrienes); cytokines including lymphokines and monokines(macrophage-derived) such as the interleukins (IL) [e.g. IL-6 regulatedby estradiol-17β, IL-8 acts as neutrophil chemotactic factor],interferons, tumor necrosis factor(s), leukotrienes, colony stimulatingfacors, transforming growth factor-beta and chemokines (inflammatorycytokines); anti-platelet antibody tests (serum, bone marrow);anti-megakaryocyte antibody tests (IFA, elution); and anti-leukocyteantibody tests (direct and indirect anti-neutrophil cytoplasmicantibody, antilymphocyte antibody, etc.).

[0130] Test 4: Diagnostic Test Panels for Gastrointestinal Function andNutritional Analysis

[0131] Patient phenotypic descriptors and genotypicdescriptors/background, plus nutritional and food supplement past andcurrent use, plus any or all of selected tests from the following list:

[0132] Serum nutrients and vitamin analysis; CBC as in Test 1; serumchemistry as in Test 1 plus magnesium and iron; urinalysis, urineculture and sensitivity, if indicated; urine fractional excretion; serumand urine amino acid analyses; serum cobalamin (vitamin B12) and folateanalysis; TLI [same as Test 2, 4)]; fecal flotation; Giardia screen,Clostridium perfringens enterotoxin test; cryptosporidiosis test (FA);toxoplasmosis test; bile acids test (resting and post-prandial); fecalalpha-₁ protease inhibitor activity. If any abnormalities are present,further investigation includes ion-coupled plasma emission spectroscopy(ICP) for mineral analysis, and electrophoresis.

[0133] Test 5: Diagnostic Test Panels for Inborn Errors of Metabolism

[0134] Characteristics related to presence of or susceptibilty tomammary cancer of the animal are determined. Biological laboratory testdata from a bodily fluid or tissue of an animal are analyzed. The testdata relate to estrogen (estradiol-17β), estrogen receptors, interleukin(IL) 6, progestefone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of presence orsusceptibilty to mammary cancer.

[0135] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0136] Genetic screening tests including blood and urine analyses formucopolysaccharides, cerebrosides, glycogen-storage diseases,phenylketones, phosphofructokinase, mannosidases, combined and specificimmunoglobulin deficiencies/dysfunctions; skin and tissue biopsies;karyotyping for genotype determination; and DNA marker analyses.

[0137] Test 6: Diagnostic Test Panels for Paternity Testing and DNAFingerprinting

[0138] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0139] Major histocompatibilty complex (MHC) Class I and II alleles[analyses of HLA, DLA, or equivalent animal antigenic specificities];genotyping; gene mapping and fingerprinting.

[0140] Test 7: Diagnostic Test Panels for Hemostatic and CoagulationFunction

[0141] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0142] Platelet count, platelet size (blood slide, mean plateletvolume), platelet morphology (light, scanning, and electron microscopy);prothrombin time; partial thromboplastin time; fibrinogen;fibrin-fibrinogen degradation products (D-dimer test); platelet functiontests (aggregation, release, clot retraction, whole blood aggregation,ristocetin cofactor); von Willebrand factor antigen and multimeranalysis; specific coagulation factor analyses (factors II, V, VII,VIII:C, IX, X, XI, XII, XIII); fibrinolytic tests (plasminogen, plasmin,antiplasmin, tissue plasminogen activator, dilute whole blood lysistest, euglobulin lysis test); anti-thrombin III test; circulatinganticoagulant tests; platelet factors 3 and 4 (heparin cofactor);protein C; protein S; kinin-kinogen tests; prekallikrein test;alpha₁-antitrypsin assay; alpha₂-macroglobulin assay; C₁ esteraseinactivator assay; anti-platelet antibody, and anti-megakaryocyteantibody tests (see Test 3).

[0143] Test 8: Diagnostic Test Panels for Vaccinal Antibody Status, andAdverse Vaccine or Potential Adverse Vaccine Reaction

[0144] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0145] 1) Serology for Vaccinal Antibody: canine distemper, canineparvovirus, canine coronavirus, canine parainfluenza virus, infectiouscanine hepatitis virus, canine bordetella, canine Lyme (borrelia),canine leptospirosis, rabies virus, feline panleukopenia virus, felineleukemia virus, feline infectious peritonitis virus, felineimmunodeficiency virus, feline calicivirus, feline herpesvirus, andequine herpes viruses (I-IV), etc.

[0146] 2) Adverse Vaccine Reaction: Same as Test 3, but especially CBC;ANA; Coombs' test; platelet count, size, and morphology; anti-neutrophilcytoplasmic antibody, marker for vasculitis; complement tests; leukocytechemotaxis tests; urine protein/creatinine ratio; anti-plateletantibody; immunoglobulin levels, especially IgG, IgA, IgM; flowcytometry (FACS) leukocyte subsets; cell cytotoxicity analysis;cytokines, especially chemokines; and complete thyroid autoantibodypanel.

[0147] 3) Potential (High Risk) Vaccine-Reaction: especially for breedssuch as the Akita, Weimaraner, Standard poodle, Eskimo Dog, harlequinGreat Dane; CBC; ANA; platelet count, size and morphology; completethyroid autoantibody panel; cell cytotoxicity analysis; cytokines; andimmunoglobulin levels, especially IgG, IgA, IgM;

[0148] Test 9: Diagnostic Test Panels for Infectious Diseases

[0149] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0150] 1) North America: Ehrlichia species (E. canis, E. risticii, E.equi, E. platys, etc.); Rickettsia rickettsei (RMSF); Borrelia species(Lyme disease); Bartonella species (B. henselae, B. vinsonii, B.clarridgeiae, B. kochlerae); systemic fungal diseases (Coccidioides spp,Cryptococcus spp, Histoplasma spp, Blastomyces spp, Aspergillus spp,ringworm); mange mites (Demodex, Sarcoptes, Chyletiella, etc.); entericdiseases (Clostridium perfringens enterotoxin); protozoan diseases(Toxoplasma spp.; Coccidia spp; Giardia spp); retrovirses (felineleukemia virus, feline immunodeficiency virus, equine infectious anemiavirus, bovine leukemia virus, caprine arthritis virus; Corona viruses(canine coronavirus, feline enteric coronavirus, feline infectiousperitonitis virus; Babesia spp (B. canis, B. gibsoni); Dirofilaria spp(heartworn); other parasitic diseases (fleas, ticks, roundworms,tapeworms, hookworms, Strongyles and other intestinal parasites); andChlamydia antigen (PCR testing).

[0151] 2) International: Same as above plus Leishmania spp; Trypanosomaspp.; Anaplasma spp; Yersina pestis.

[0152] Test 10: Other Diagnostic Tests

[0153] Patient phenotypic descriptors and genotypicdescriptors/background, plus any or all selected tests from thefollowing list:

[0154] Pathology (anatomic, histological, cytologic,immunohistochemical, electromicroscopy, FACS); blood typing; bone marrowanalysis and specific immunohistochemical staining; RFLP and PCR testing(applicable to many of the above categories); IFA and FA testing; ELISAtesting, cell cytotoxicity testing, cytokine testing (see Test 3, othercytotoxic cell and mitochondrial tests); markers of neoplastic andparaneoplastic change (cancer); neurotransmitters including serotonin,the gamma-aminobutyric acid (GABA), the glutamate, the dopamine, theglycine, the aspartate, the acetylcholine, the norepinephrine, thehistamine, the substance P, the vasopressin, the vasoactive intestinalpeptide, the neurotensin, or the other neuropeptides; and amino acidprofiling.

[0155] Overall System

[0156]FIG. 1 is an overview of the web-based system to provide access tothe invented database management system. With this system multipleusers, for instance, remote users 8, access the web site 4 using theInternet 6. Each of the users 8 has a computer terminal with the Sappropriate software for accessing Internet. The users 8 may be unknownto the web server computers 10 and 12. Each user 8 is allowed to browsethe web site and explore how the system functions.

[0157] There are several aspects to maintain security of informationmaintained in the database server 22 and a banking system 28. A firewall20 prevents any user 8 from accessing any of the components behind thefirewall 20. In this way the users 8 have access to the web servercomputers 10 and 12, but only have access to the database server 22through the firewall 20. The database server 22 maintains, among otherthings, various database fields with respect to each of the healthprofiles of subjects and the genetic information of a subject andgroups. The database 22 maintains the services with a designationassociated to determine what health assessment data and genetic data canbe browsed by the users 8. Each of the web server computers 10 and 12allow users 8 to view subject and group categories and actual servicesand data products which are available from the database.

[0158] The web server computers 10 and 12 can be identical and can beduplicated as additional load or growth on the system occurs. The webserver computers 10 and 12 share the responsibility for servicing theusers of the site. This arrangement provides for expandability of thesystem by merely adding additional web server computers as necessary.

[0159] Preferably, the system includes an appropriate computer terminal24 for interfacing with independent financial institutions which areconnected on-line via the serial connection 26 to the financialinstitution computers 28. This allows automatic real time confirmationof the access of health profile and genetic data services and products.Once a user requires access to a product or service, the user goesthrough an identification or registration process and the exchange offinancial information to allow for credit or debit card payment of thepurchase. This is verified, confirmed and authorized by the appropriatebank system institution 28. Confirmation of the purchase or deposit ofdata, or a service is made by a mail server 34 which sends an E-mail tothe user 8 confirming the purchase or deposit. The mail server 34 allowsfor mail to be received and sent out. Security of the various databasesis maintained. Alert messages are generated when an unauthorized accessis attempted. Verification messages, authorization messages andconfirmation messages are generated as appropriate.

[0160] The database server 22 is also designed to interact with an inputcomputer 32 operated by a CDPR. A firewall 30 serves to preventunauthorized access to the database server 22 or to the input computer32. The input computer 32 can input health profile data and genetic datato the database, after appropriate access and/or passwords are enteredinto the system. Similarly, users 8 through their own computers can useappropriate access codes and passwords to access input data to thedatabase server 22. This is tightly controlled for security reasons. Thedata may only be added to an independent sub-database of the data server22, and only after scrutiny by the CDPR operator of the database throughinput computer 32, will this data from users 8 be subsequently added tothe main database server 22.

[0161]FIG. 2 is an illustration of the Internet and its use in thesystem of the invention. The Internet 6 is a network of millions ofinterconnected computers 40 including systems owned by Internetproviders 42 and information systems 44 such as America Online (TM).Individual or corporate users may establish connections to the Internetin several ways. A user on a home PC 46 may purchase an account throughthe Internet provider 42. Using a modem 48, the PC user can dial up theInternet provider to connect to a high speed modem 50 which, in turn,provides a full service connection to the Internet. A user 52 may alsomake a somewhat limited connection to the Internet through a system 20that provides an Internet gateway connection 54 and 56 to its customers.The database 22 is also connected into the Internet 6 through anappropriate modem or high speed or direct interface 58. The database 22is operable and maintained by the CDPR operator computer 60. Users ofthe databases of the invention would access the Internet in anappropriately selected manner.

[0162]FIG. 3 is a block diagram of an exemplary computer system 100 forpracticing various aspects of the invention. The computer system 100includes a display screen or monitor 104, a printer 106, a disk drive108, a hard disk drive 110, a network interface 112, and a keyboard 114.The computer system 100 includes a microprocessor 116, a memory bus 118,random access memory (RAM) 129, read only memory (ROM) 122, a peripheralbus 124, and a keyboard controller 126. The computer system 100 can be apersonal computer, such as an Apple computer, e.g., an Apple Macintosh(TM), an IBM (TM) personal computer, or a compatible, a workstationcomputer, such as a Sun Microsystems (TM) or Hewlett-Packard (TM)workstation, or some other type of computer.

[0163] Microprocessor 116 is a general purpose digital processor whichcontrols the operation of computer system 100. Microprocessor 116 can bea single-chip processor or can be implemented with multiple components.Using instructions retrieve from memory, the microprocessor 116 controlsthe reception and manipulation of input data and the output and displayof data on output devices.

[0164] Memory bus 188 is used by the microprocessor 116 to access RAM120 and ROM 122. RAM 129 is used by microprocessor 116 as a generalstorage area and as scratch-pad memory, and can also be used to storeinput data and processed data. ROM 122 can be used to store instructionsor program code followed by microprocessor 116 as well as other data.

[0165] Peripheral bus 124 is used to access the input, output, andstorage devices used by computer system 10. These devices include thedisplay screen 104, printer device 106, disk drive 108, hard disk drive110, and network interface 112. The keyboard controller 126 is used toreceive input from the keyboard 114 and send decoded symbols for eachpressed key to microprocessor 116 over bus 128.

[0166] The display screen or monitor 104 is an output device thatdisplays images of data provided by microprocessor 116 via peripheralbus 124 or provided by other components in computer system 100. Theprinter device 106 when operating as a printer provides an image on asheet of paper or a similar surface. Other output devices such as aplotter, typesetter, etc. can be used in place of, or in addition to theprinter device 106.

[0167] The disk drive 108 and hard disk drive 110 can be used to storevarious types of data. The disk drive 108 facilitates transporting suchdata to other computer systems, and hard disk drive 110 permits fastaccess to large amounts of stored data.

[0168] Microprocessor 116 together with an operating system operate toexecute computer code and produce and use data. The computer code anddata may reside on RAM 120, ROM 122, or hard disk drive 120. Thecomputer code and data could also reside on a removable program mediumand loaded or installed onto computer system 100 when needed. Removableprogram mediums include, for. example, CD-ROM, PC-CARD, floppy disk andmagnetic tape.

[0169] The network interface circuit 112 is used to send and receivedata over a network connected to other computer systems. An interfacecard or similar device and appropriate software implemented bymicroprocessor 116 can be used to connect computer system 100 to anexisting network and transfer data according to standard protocols. Assuch he computer system is connectable through an interface device withthe Internet 6.

[0170] Keyboard 114 is used by a user to input commands and otherinstructions to computer system 100. Other types of user input devicescan also be used in conjunction with the present invention. For example,pointing devices such as a computer mouse, a track ball, a stylus, or atablet can be used to manipulate a pointer on a screen of ageneral-purpose computer.

[0171] The present invention in relation to the animal databasemanagement of data can also be embodied as computer readable code on acomputer readable medium. The computer readable medium is any datastorage device that can store data which can be thereafter read by acomputer system. Examples of the computer readable medium includeread-only memory, random-access memory, magnetic data storage devicessuch as diskettes, and optical data storage devices such as CD-ROMs. Thecomputer readable medium can also be distributed over network coupledcomputer systems so that the computer readable code is stored andexecuted in a distributed fashion.

[0172] Specific System

[0173]FIG. 4 illustrates a browser system for use with the databasesystem of the invention. A browser goes through a number of preliminaryscreens and logic steps, and reaches a screen 60 entitled “Next Entry”.This screen provides data details or information generally indicated as62. Clicking on any of these categories allows the user to reviewdatabase details 64, data specific details as generally indicated by 66.In this way, the user can index through a number of screens to getinformation regarding the different databases of the system. Inaddition, clicking on any of the triggers 70, 72, 74 and 76 is possible.These correspond to HOW IT WORKS, SECURITY, EXTENDED DATA andPRE-REGISTRATION. Clicking on trigger 70 provides the user withinformation on how the process works, explains the system, and providesdetails on how the user can participate in the database and obtain dataor input data. Clicking on trigger 72 provides details regardingsecurity of the system and automatic payment. In some cases, productsand services are offered with extended data and clicking on trigger 74which can provide details of the extended. data and explains that thismay only be available on certain services or products.

[0174] Trigger 76 allows a user to pre-register and obtain user IDnumber. This ID number is combined with financial information retainedin the database in an encrypted form. The pre-registration trigger 76follows with step 78 which is to gather personal information such ascredit card number and expiry date to allow for automatic payment. Step80 is to validate a current existence in the database, if this occurs.With a negative answer, the user is directed into a registration processindicate as 82. A user ID is assigned and a password is entered. Thisinformation is maintained in a portion of the database 22. At 84 theuser is provided a screen identifying the user ID at screen 86. If theuser already exists, the registration process is rejected at 88 and theuser is advised of the information at the display 86. The screen at 86would also represent the information which is available in the database22.

[0175] In FIG. 5 there is shown a basic block diagram of the componentsmaking up the CDPR. There is the phenotype database or physical healthdatabase 200 and a genotype database or genetic information database201. These are contained in part of the overall CDPR database 202. Userinput 203 can be obtained from a remote user such as a veterinarian,owner, breeder, or the operator of the database, an agent or researcher.The output from the database 204 could be to the veterinarian, owner,breeder, operator, agent or researcher.

[0176]FIG. 6 shows a relationship for retrieving data from the database202. The user 8 is represented here as a veterinarian, owner, breeder,operator, or researcher 203 who accesses the CDPR 202 accesses a firstscreen through a computer network 6 which inquires about informationabout the user. An access request message is sent, and an appropriateaccess enabling message is transmitted. The user 203 can obtain partialor full access to the CDPR 202 according to the scale of authority givento the user 203 to access data. There is a computer program system 205to ensure that payment is made as appropriate before access to the CDPR202 is granted. In some situations, the appropriate access code 204 canpermit bypassing the payment requirement 205 as indicated by line 206.Payments 205 through the computer program can be effected by a creditcard entry and automatic transfer to a financial institution on behalfof the operator of the CDPR 202. Such payment for access to the databaseis effected by a system which is well known in the art. The financialinstitution will appropriately credit the operator of the CDPR 202 in afinancial manner as established between the operator and the financialinstitution.

[0177] Within the CDPR 201 there is the ability to access the physicalhealth phenotype database 200, the genotype database 201, and otherdatabases 207, 208 and 209, respectively. The phenotypic and genotypicinformation together with other database information can be presented ona single screen or monitor or other viewing means, for instance, hardcopy format. The access therefore can be to multiple databases containedwithin the CDPR 202. After accessing the physical health database 200,the user obtains an analysis report from module 210. The user is thenable to read the analysis as indicated by 211 and output the analysisfrom the read-out 211 as indicated by output 212. The output 212 can bea computer screen read-out, fax or voice information.

[0178] The physical health or phenotype database 200 is subject or groupspecific. In other words, the data obtained in that database is specificto a particular animal or animal group (breed, family, species, etc.)which has been the subject of a laboratory or research biologicalexamination such that fluid or tissue samples have been subject toanalysis in one or more laboratory or research environments. Thesebiological reports can include those from specimens of blood, urine,other body fluids, skin, eyes, skeletal and other tissues. The PTdatabase 200 has the ability to store the subject specific informationas required within the CDPR 202.

[0179] The genotype specific or genetic disorder or disease data isretained in the database 201 within the CDPR database 202. This data iseither subject specific, family specific, breed specific, speciesspecific, disorder specific, or disease specific, and is group orsubject specific. The user can access the genotype database 201 andobtain a read-out 213 which can then be transmitted along line 214 to anoutput 212 in the same manner that the physical health assessment isobtained as an output.

[0180] In an alternative approach, the reader can request an analysis215 from the genotype database as indicated by line 216. This analysiscan receive data along line 217 from the analysis information of thephysical health assessment. Interpretation of the PT and GT can beobtained as indicated by 218, and this can then be outputted asindicated along line 219. The interpretation of PT and GT 218 can beperformed by an algorithm relating to the coefficients andpredictability of information relating to disorders, disease andlongevity when considering the data from the two databases PT 200 and GT201. This can be done automatically and outputted along line 219, orthere can be an expert interface 220 using skilled personnel tointerpret the data of block 218, and this can, in turn, be outputtedalong line 221 to the output 212.

[0181] Database 207 can be a genetic marker database, and theinformation from that database can be directly input into the outputthrough a read-out 222 and 223 to the output 212. Alternatively, thedata from database 207 can be added to the interpretation section 218 ofthe physical health and genetic information by directing the data alongline 224. This data can then be made the subject of the output along theline 219 and 221 as required.

[0182] Similarly other databases 208, 209, respectively, have read-outs225 and 226 which can be directly coupled along lines 227 and 228 to theoutput, or can be directed optionally along lines 229 and 230 to theinterpretation module 218. It can then be the subject of interpretationfor an expert interface 220 review which is, in turn, made the subjectof the output 219 and 221.

[0183] In each of the output lines 219, 221, 222, 223, 227, 228, and 214there is also provided an encryption program 231 which can be optionallyused in the system. The output 212 can include paper, electronic, orvoice read-out as is required.

[0184] In this manner, the output 212 provides a compilation whichcombines the physical health and genetic information relating to asubject, the breed, disease, disorder and lifespan, thereby enabling thereceiver of the output 212 to use the compiled information in a mannerto facilitate breeding criteria which can be important in relation toanimals which are usually inbred or line bred. The information can alsobe used to facilitate on-going monitoring of particular subject animals.The data from this system can be used to manipulate and regulatebreeding, health, and longevity effectively among animals.

[0185] The system of the invention is further described with regard toFIG. 7 which is a system for inputting data to the CDPR 202. Heremultiple users 203, which can be a remote user such as a laboratory, abreeder. an owner, hospital, agent, or an operator of the CDPR 202accesses the system through module 204 which, in turn, accesses the CDPR202. Appropriate access request and access enable messages are sent.Within the CDPR 202 there is a physical health or phenotype module 200,a genetic or genotype data module 201, and other database modules 207,etc. After accessing the CDPR 202, additional data can be added to themodules 200, 201, 207, etc. through any of the users 203, if authorized.Depositing data into each of the modules 200, 201 and 207 can optionallyrequire the payment to the operator of the CDPR 202 as is indicated byblock 205. This system can function in the same manner as the retrievalof data from CDPR 202.

[0186] The stored data in each of the blocks 200, 201, and 207 can beset up as indicated by block 232 in a manner which is restricted orunrestricted to selected users 203. This may be necessary according tothe protocols governing the inputted data to the different databases. Insome cases, the waiving of deposit fees is made in the interest offreedom of the database to subsequent users who wish to retrieve datafrom the database. After storage of the data as indicated by block 234,the user 203 exits CDPR 202 as indicated by block 233.

[0187] As is apparent, the physical health or phenotype profile ofsubject animals is dynamic and grows as more data is added into thesystem. Likewise, the genetic genotype database also grows as increasingresearch of particular subjects, breeds, and the like is obtained. Thedeposit of new information into the CDPR 202 is regulated in a mannerthat the data cannot distort the databases 202 in an in appropriatemanner. Likewise, users 203 cannot access the secured databases withinCDPR 202 in an inappropriate manner.

[0188] Different algorithms regulate the relationship between the healthprofile, the genetic data, and other data relating to animals. Thesealgorithms determine the probabilities, possibilities, and likelihood ofdisorders and disease in subject animals and offspring animals. They areused as predictors of the future evolvement of health of the animal.Examples of Inter-relationship and Algorithm Inter-relationship of thePhenotype and Genotype Data Bases

[0189] In one example the genetic influence on behavior and behavioraldisorders accounts for less than half of the phenotypic expression ofbehavior and behavioral differences. However, behavior is the mostcomplex phenotype, because it reflects not only the functioning of thewhole being but also is dynamic and changes in response to environmentalinfluences. These results are most dramatically seen in purebred animalsbecause they have been inbred and line-bred to select for a particularbehavior and conformation, even though the genotype of purebred breedsshows almost no variation over 100 years. Examples of this are all thedifferent purebred dog breeds which currently exist, and have widelydisparate size, weight, temperament and lifespans.

[0190] Accordingly, if the results of a mostly phenotypic databaseindicate abnormal thyroid function, then by relating this to the mostlygenotypic and combined database categories of breed, age and sex, it ispossible to determine whether the subject has or does not have heritablethyroid disease, or is likely to develop this condition within apredicted period of time.

[0191] Similarly, if the phenotypic database indicates elevated bloodand urine glucose levels, then by relating this to the genotypic andcombined database categories of weight, age, sex, breed and reproductivehistory, it is possible to determine that the subject has diabetes thatis likely to be of an heritable basis.

[0192] Another example relates the phenotypic database indicating lowblood von Willebrand factor level to the genotypic and combined databasecategories of breed, age, sex, and clinical and family history, wherebyit is possible to determine whether the subject has the inherited oracquired form of von Willebrand disease.

[0193] Analyzing the data from the CDPR 102 in the manner of the presentinvention permits for genetic screening, health assessment profiling,and the diagnostic, prophylactic, and therapeutic management of animals.

[0194] An exemplary server performs all the operations of a conventionaldatabase system and performs additional operations in accordance withthe present invention as has been discussed. The server includes acentral processing unit (CPU) together with associated memory forprocessing information about different animals species and history. Theinquiries concern animals species and history and inquiries and requestsfor health profiling and genetic information, and providing healthprofiles and genetic information. The CPU is coupled to the database andto users via a communications port. The CPU is also coupled to anelectronic mail processor for processing and storing (in a storagedevice) e-mail messages transmitted between the CPU and various agents,users and the like. The CPU is further coupled to a data storage device.A data storage device may include a variety of the databases. The systempermits for the requesting, storing and providing of data with respectto animal phenotypic information and genetic information. The format andcontent of the databases have been discussed in detail.

[0195]FIG. 8 presents an overview of the laboratory instrumentsapparatus, system, and method operable with the present invention inrelation to a CDPR 202. The present invention allows access by remoteusers with computers or processors 100 to receive and access data onspecimens. Using the Internet 6 or other computer network orcommunication link capability, the remote user 8 sends a message torequest access to the services provided by the laboratory or operatorwhich has a CDPR 202. If access to the CDPR 202 is granted, a message issent to the remote user computers 100. This message includesinstructions enabling the remote user 8 to define and access data storedin the CDPR 202.

[0196] In one form of the invention, the desired data is based on thesubmission of test specimens of a specific animal to the laboratory. Insome other cases health profile test data 200 can be inputted into theCDPR 202 having the genetic database 201. The CDPR 202 can perform ananalysis and correlation between the health profile database 200 and thegenetic database 201.

[0197] Using the communications link, the remote user 8 communicateswith the laboratory or the CDPR 202. Specimens can be packaged andphysically transported to the laboratory site via commercially availablecommon carriers, such as the postal service or courier services. Whenthe packages arrive, the laboratory places them in storage, or the testsare performed. Instruments 300 perform the tests to obtain data asspecified by the remote user 8. The biohazardous samples can be disposedof a waste material. The test results, or output is provided as part ofa health profile database 200 of the CDPR 202 and is available to theremote user 8.

[0198] If desired, the remote user 8 can arrange to have the data storedin the CDPR 202, made available to other remote users 8. The remote user8 can also request the laboratory to perform analysis on the healthprofile data 200 generated.

[0199] In one embodiment, the communications link is a computer networkand the message transfer modality is, for instance, the Internet 6,and/or an Intranet and/or an Extranet. The network systems areparticularly suited to the application described herein since it offersglobal or widespread accessibility and high speed data transfer of largeamounts of information.

[0200] A security unit allows remote users to designate who haspermission to view or use their data. Feasible options for theseinformation management requirements include: access by the submittingremote users only, access by certain designated researchers andcollaborators, time-embargoed data followed by wider access, andunrestricted access by all. A commerce unit can implement functionsrelated to the business aspects of the CDPR facility, including billing,inventory management of support materials.

[0201] A multimedia unit comprises means to store, manipulate, andpresent audio, graphical, video information. This information mayinclude a video explaining how the CDPR is used, a visual depiction ofthe data, methodology, or a comment regarding the background of thedata. The multimedia unit may also implement subscription functions, sothat updated data automatically provided to remote users or otherinterested parties.

[0202] The operations performed by the present invention begins when thecontroller receives an access request message from the remote user via acommunication link. Using information in the access request message andany other available information, the controller determines if the remoteuser is authorized to access the CDPR 202. If so, an access enablingmessage is transmitted from the controller to the remote user 8. Theaccess enabling message can comprise a set of computer instructionstransmitted over the Internet 6 which is downloaded into the remote usermemory for execution by the remote user processor. These instructionsmay be enabling, that is, they may allow direct communication betweenthe remote user 8 and the CDPR 202 with no further need for thecontroller. In another embodiment, the access enabling message maysimply comprise a password or other enabling message which allows theremote user 8 to proceed. The remote user 8 can access or submit data tothe CDPR 202 according to different protocols and regimes and securityarrangements.

Conclusion

[0203] As is clear the tests above which relate to at least one ofendocrine function, immunologic function, gastrointestinal function andnutritional analysis, metabolism, paternity, DNA fingerprinting,hemostasis and coagulation function, vaccinal antibody status, adversevaccine reaction, infectious disease, pathology, anatomic, histological,cytologic, immunohistochemical, electromicroscopy, FACS, blood typing,bone marrow analysis and immunohistochemical staining, and allergyreaction about the animal provide useful information. This is in amanner previously not obtained.

[0204] As the above demonstrates, there is a need for providing dataanalysis and dissemination services to a wide variety ofglobally-distributed remote users. There is a need for providing asystem for inputting, storing and retrieving data related to animalhealth assessment and genetics in a manner which permits for theeffective use of this information.

[0205] The system also permits for the access to the genetic and/orphenotype data through a password and a system whereby access to thedata generates a fee. This system permits for the access or to providedata with regard to credit cards or the like to ensure that the fee istransmitted automatically to a banking system for the account of thedatabase when such data is accessed.

[0206] This system also provides for a situation wherein payments can bemade by credit card for requests to perform health assessment profilesand secure genomic mapping and genetic screening information. Suchbioinformatics system can also permit for the automatic payment for suchservices and products to the banking system of the database orlaboratory. As such, the database may require that the payments beguaranteed, for instance by supplying a credit card number with arequest for performance of services and a product, and for the retrievalof such data.

[0207] A user can submit a request to the database in any number ofways. For example, the request can be submitted via on-line directconnection, namely through a computer network such as the Internet. Anintermediate researcher such as a veterinarian or scientist other thanthe owner could also submit the request on behalf of the owner using thee-mail capabilities of the central database system. Alternatively, theuser can submit the data via an interactive voice response unit coupledto the database system of the supplier. In some situations, the databasesupplier can decide whether to supply the health assessment informationand/or genomic mapping and genetic screening information based on thecriteria of the user or its intermediary agent. Such user orintermediary agent can be notified of the decision via the interactiveresponse unit or a live operator.

[0208] The user or agent can log into the database system and obtain thenecessary records relating to an animal physical health and/or geneticancestry or offspring. The database system can transmit in real time oron a periodic basis as determined, thereby, providing informationregarding the health assessment or the genetic background and forwardthis information to the user and/or its intermediary agent.

[0209] The data storage devices of the invention include a variety ofdatabases including a database relating to the phenotypic data of aparticular species, a database relating to health assessment or otherphenotypic data of particular animals in a particular species, andgenetic characteristics of different species and different family treesrelating to different species. The family trees would containinformation including the origin, genomic map, and parental lines of aspecies and records of health and performance of a species. Thesedatabases are interrelated in an analytical manner and in accordancewith different algorithms of permutations and probabilities tofacilitate useful output information based on the combination of data inthe genotypic and the phenotypic databases, and the selected databases.

[0210] Many other examples of the invention exist, each differing fromothers in matters of detail only. The invention is to be determinedsolely by the following claims.

REFERENCES

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What is claimed is:
 1. A method of health profiling an animalcomprising: obtaining genetic data of the animal, and health assessmentdata of the animal; combining the genetic data or health assessment datawith at least one of: a. the neurotransmitter data relating to thetemperament of the animal; b. the neurotransmitter data relating to thelongevity of the animal; c. data assessing the bodily fluid and tissueimmune stimulation reaction, neoplastic or paraneoplastic change, orcellular inflammatory response of the animal; d. metabolic marker of theanimal for inherited organ dysfunction or dysplasia; e. a physiologic orgenetic marker for autoimmune thyroiditis; f. data assessing thepresence of or susceptibilty to mammary cancer of the animal; g. dataassessing the integrity of immune surveillance mechanisms of the animal;h. data assessing the risk of inherited bleeding disease or disorder ofthe animal; and producing a report from these data, the report includingan evaluation of health, disease and disorder probabilities andlongevity of the animal.
 2. The method of claim 1, comprising the stepof storing the report in a central database processing resource.
 3. Themethod of claim 2, including sending an access request message from theremote user via a communications link, and the communications link isselectively a computer network, preferably including the Internet, theaccess request being for obtaining the report from the central databaseprocessing resource.
 4. The method of claim 1, including the steps ofcommunicating between a remote user and the central database processingresource through a computer network, providing credit card informationof the remote user prior to providing the report to the remote userafter charging a credit card for such data.
 5. A method of healthprofiling an animal to determine characteristics related to thetemperament of the animal and comprising the steps of: analyzingbiological laboratory test data from a bodily fluid or a tissue of ananimal, such test data being related to a neurotransmitter activity ofthe animal; analyzing biological test data relating to a healthassessment of the animal together with genetic data related to thatanimal; and producing a report from these data, the report including anevaluation of the temperament of the animal.
 6. The method of claim 5,including obtaining data related to at least one of the value ofserotonin, the gamma-aminobutyric acid (GABA), the glutamate, thedopamine, the glycine, the aspartate, the acetylcholine, thenorepinephrine, the histamine, the substance P, the vasopressin, thevasoactive intestinal peptide, the neurotensin, or the otherneuropeptides of the animal.
 7. The method of claim 5, includingreporting the health profile of that animal to a remote user.
 8. Amethod of health profiling an animal to determine characteristicsrelated to the immune stimulation reaction, or presence of neoplastic orparaneoplastic change, or cellular inflammatory response of the animalcomprising the steps of: analyzing biological laboratory test data froma bodily fluid or tissue of an animal, such test data being related toat least one of a cytokine, chemokine, or lymphocyte marker of theanimal; analyzing biological test data relating to a health assessmentof the animal together with genetic data related to that animal; andproducing a report from these data, the report including an evaluationof the immune stimulation reaction, or presence of neoplastic orparaneoplastic change, or cellular inflammatory response of the animal;9. The method of claim 8, including obtaining data related to at leastone of the value of cell cytotoxicity markers, cytokine and chemokinelevels, immunoglobulin levels, type and amount of lymphocyte subsets andlymphocyte markers, and markers of neoplastic or paraneoplastic changeof the animal.
 10. The method of claim 8, including reporting the healthprofile of that animal to a remote user.
 11. A method of healthprofiling an animal to determine characteristics related to inheritedorgan dysfunction or dysplasia of the animal comprising the steps of:analyzing biological laboratory test data from a bodily fluid or tissueof an animal, such test data being related to a metabolic marker of theanimal; analyzing biological test data relating to a health assessmentof the animal together with genetic data related to that animal; andproducing a report from these data, the report including an evaluationof the inherited organ dysfunction or dysplasia of the animal.
 12. Themethod of claim 11, including obtaining data related to at least one ofthe value of the methyl malonic acid, the fucose-containing cellmetabolites, blood or urine urate or uric acid metabolites,normoglycemic glycosuria, amino acid uria, mannosidase containing cellmetabolites, amyloid deposition in tissues, neuronal ceroid lipofuscindeposition, and deposition of gangliosides and other lysomal storagesubstrates of the animal.
 13. The method of claim 11, includingreporting the health profile of that animal to a remote user.
 14. Amethod of health profiling an animal to determine characteristicsrelated to autoimmune thyroiditis of the animal comprising the steps of:analyzing biological laboratory test data from a bodily fluid or tissueof an animal, such test data being related to a physiologic or geneticmarker for thyroiditis in the animal; analyzing biological test datarelating to a health assessment of the animal together with genetic datarelated to that animal; and producing a report from these data, thereport including an evaluation of the thyroiditis condition of theanimal.
 15. The method of claim 14, including obtaining data related toat least one of the value of a comprehensive thyroid autoantibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities) of the animal.
 16. Themethod of claim 14, including reporting the health profile of thatanimal to a remote user.
 17. A method of health profiling an animal todetermine characteristics related to the presence of or susceptibilty tomammary cancer in the animal comprising the steps of: analyzingbiological laboratory test data from a bodily fluid or tissue of ananimal, such test data being related to a sex hormonal or a tissueinflammatory marker of mammary cancer; analyzing biological test datarelating to a health assessment of the animal together with genetic datarelated to that animal; and producing a report from these data, thereport including an evaluation of the presence of or susceptibilty tomammary cancer in the animal.
 18. The method of claim 17, includingobtaining data related to at least one of the value of the estrogen(estradiol-17β), estrogen receptors, interleukin (IL) 6, progesterone,and progesterone receptors of the animal.
 19. The method of claim 17,including reporting the health profile of that animal to a remote user.20. A method of health profiling an animal to determine characteristicsrelated to the tissue environment of the eye and brain of the animal,which are sites protected from the normal immunologic surveillancemechanisms, and comprising the steps of: analyzing biological laboratorytest data from a bodily fluid or tissue of an animal, such test databeing related to the soluble and cellular immune inflammatory responsemediators of the animal; analyzing biological test data relating to ahealth assessment of the animal together with genetic data related tothat animal; and producing a report from these data, the reportincluding an evaluation of the immune surveillance mechanisms of theanimal.
 21. The method of claim 20, including obtaining data related toat least one of the value of the soluble and cellular immuneinflammatory response mediators selectively at least one of the cytokinelevels, chemokine levels, immunoglobulin levels, or lymphycyte susbsetmarkers.
 22. The method of claim 20, including reporting the healthprofile of that animal to a remote user.
 23. A method of healthprofiling an animal to determine characteristics related to theinherited tendency to bleed excessively are determined, and comprisingthe steps of: analyzing biological laboratory test data from a bodilyfluid or tissue of an animal, such test data being related to theinherited tendency of the animal to bleed excessively; analyzingbiological test data relating to a health assessment of the animaltogether with genetic data related to that animal; and producing areport from these data, the report including an evaluation of thehemostatic and coagulation function of the animal.
 24. The method ofclaim 23, including obtaining data related to at least one of the valueof the platelet count, platelet size, platelet morphology; prothrombintime; partial thromboplastin time; fibrinogen; fibrin-fibrinogendegradation products; platelet function tests; von Willebrand factorantigen and multimer analysis; specific coagulation factor analyses;fibrinolytic tests; anti-thrombin III test; circulating anticoagulanttests; platelet factors 3 and 4 protein C; protein S; kinin-kinogentests; prekallikrein test; alpha₁-antitrypsin assay;alpha₂-macroglobulin assay; C₁ esterase inactivator assay; anti-plateletantibody, and anti-megakaryocyte antibody tests.
 25. The method of claim23, including reporting the health profile of that animal to a remoteuser.